Recall Z-0789-2013— Linvatec Corp. dba ConMed Linvatec
Class II · Terminated
Class II FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2012-11-15, terminated 2013-05-22. FDA's recall record names no specific 510(k) clearance for this event. Product: ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch. Reason: ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm..
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-15
- Terminated
- 2013-05-22
- Firm location
- Largo, FL, United States
Product description
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Reason for recall
ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
Data sourced from openFDA. This site is unofficial and independent of the FDA.